Fragile X Syndrome
Conditions
Keywords
fragile X syndrome, autism spectrum disorder
Brief summary
To explore the efficacy, safety and tolerability of STX209 (arbaclofen) administered for the treatment of social withdrawal in adolescents and adults with fragile X syndrome (FXS)
Interventions
DRUGarbaclofen
orally disintegrating tablet
DRUGplacebo
orally disintegrating tablet
Sponsors
Seaside Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Molecular documentation of the full FMR1 mutation * Current pharmacological treatment regimen has been stable for at least 4 weeks prior to Screening. * Subjects with a history of seizure disorder must currently be receiving treatment with antiepileptics and must have been seizure free for 6 months, or must be seizure free for 3 years if not currently receiving antiepileptics. * If the subject is already receiving stable non-pharmacologic educational, behavioral, and/or dietary interventions, participation in these programs must have been continuous during the 2 months prior to Screening
Exclusion criteria
* Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. * Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study. * Subjects who have taken another investigational drug within the last 30 days. * Subjects who are not able to take oral medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aberrant Behavior Checklist - FXS Social Avoidance Subscale | At 8 weeks of treatment |
Countries
United States
Outcome results
None listed